Kornimate/medical-research-clean huggingface dataset:
xenon inhalation during orthopaedic surgery in elderly subjects.

Conditions: Anaesthesia; Postoperative Cognitive Function

Summary: the primary objective was to explore the feasibility of inhaled xenon for sedation in terms of its effect on postoperative cognitive function in elderly, in comparison with the postoperative cognitive function found after iv propofol sedation in the same population.the secondary objectives were designed to assess the feasibility of xenon sedation in terms of its effects on different neuropsycho-logical test variables, vital signs, sedation levels and safety in elderly orthopaedic subjects.

primary endpoint: - the primary efficacy parameter was a combined score based on the seven variables derived from four validated neuropsychological tests of cognitive function; visual verbal learning test, concept shifting test, stroop color word interference test and letter digit coding test. the parameter was used for comparing changes in test results between the screening and first postoperative follow-up testing for the treatment groups.secondary endpoints:- cognitive performance changes from baseline to the first post-operative follow-up judged separately for each of the seven variables from the changes in the test results.- cognitive performance changes from baseline to the second postoperative follow-up judged separately and globally for each of the seven variables from the changes in test results.- adequacy of ventilation (respiratory rate and pulse oximetry)- adequacy of xenon sedation by monitoring depth of unconsciousness, signs of airway irritation, need for additional sedatives, time to recovery from anaesthesia. - technical performance of xenon delivery device

Eligibility criteria:
inclusion criteria: * male or female subjects ≥ 60 years of age. * american soc. of anaesthesiologists physical status classification (asa) i-iii status \[27\] * referred for elective orthopaedic knee surgery with an anticipated duration of \> 45 min * expected to remain in hospital for at least 3 days * expected to be able to comply with the study protocol throughout the study period * mini mental state examination (mmse) score \> 23 * informed consent given exclusion criteria: * disease of the cns (infectious, metabolic, tumours, dementia, epilepsy, major psychiatric disease, confusion/ delirium according to diagnostic \& statistical manual of mental disorders (dsm) iv criteria) * contradiction for spinal anaesthesia * contradiction for laryngeal mask * regular use of tranquillisers, or antidepressants, if prescribed by psychiatrist for psychosis or depression * undergone neuropsychological testing within the last year * unable to follow study procedures, illiteracy, or poor comprehension of the language used in the psychometric tests * severe visual or auditory disorder * alcoholism or drug abuse cns disease bmi \> 35 inab

Keywords: anaesthesia surgery postoperative neuropsychological test
study of cabergoline for prevention of ovarian hyperstimulation syndrome (ohss) in in vito fertilization cycles and derivation of ohss biomarkers

Conditions: Ovarian Hyperstimulation Syndrome

Summary: the purpose of this study is to determine whether cabergoline is effective in reducing the incidence and severity of ovarian hyperstimulation syndrome (ohss), especially for severe cases; and to derive biomarkers for the risk of developing ohss.

severe ovarian hyperstimulation syndrome (ohss) occurs in up to 2% of in-vitro fertilisation (ivf) cycles, resulting in accumulation of fluid in peritoneal, pleural and pericardial cavities, haemo-concentration with resultant venous thromboembolic phenomena, reduced perfusion of vital organs, renal failure, acute respiratory failure, and even death. the long term aim is to develop a comprehensive strategy in reducing the incidence and severity of ohss in in-vitro fertilisation (ivf) cycles. our short term aim (2-3 years) is to test the ability of the dopamine receptor agonist cabergoline in reducing the incidence and severity of ohss in high risk women undergoing controlled ovarian hyperstimulation (coh) in fresh ivf cycles through a reduction in vasoactive cytokine levels, specifically in serum vascular-endothelial growth factor (vegf). specifically we will: 1. conduct a randomised double-blind placebo-controlled trial in women at high risk of developing ohss during a fresh coh-ivf cycle 2. investigate the serum and follicular fluid levels for potential biomarkers of ohss.

Eligibility criteria:
inclusion criteria: * patients with more than 20 oocytes collected after coh in both gonadotropin-releasing hormone (gnrh) agonist and antagonist cycles exclusion criteria: * patients with allergy to dopamine agonists * patients who undergo in-vitro maturation cycles * patients where gnrh analogues have been used to trigger oocyte maturation in antagonist cycles
different anesthetic strategies on postoperative cognitive function and delirium in patients undergoing cardiac surgery

Conditions: Delirium; Condition; Anesthesia

Summary: this is a prospective, multi-center, double-blind, randomized clinical trials.

prospective randomized multi-center trial involving about 502 subjects will be enrolled in 3 centers. patients will be randomized to two groups in equal proportion. investigators set a hypothesis that precision cardiac anesthesia, which involves the modification of several crucial anesthetic modalities, would reduces the incidence of postoperative cognitive function and delirium in patients undergoing cardiac surgery.

Eligibility criteria:
inclusion criteria: 1. aged≥18 years; 2. asa:i to iii; 3. hemodynamic stability, lvef≥40%; 4. cardiac surgery including cabg, valve surgery, cabg combined with valve surgery, surgical repair of asd,vsd and atrial myxoma, and other types. exclusion criteria: 1. declined to get involved; 2. emergency cases, heart transplantation; 3. severe hepatic insufficiency (child-pugh grades c),severe renal insufficiency (requirement of renal replacement therapy); 4. previous history of drug and alcohol abuse,allergy to general anesthetics; 5. preoperative severe dementia, language barrier and mental illness 6. preoperative schizophrenia, epilepsy, stroke and parkinson's disease 7. previous history of craniocerebral injury or neurosurgery; 8. any other conditions that are considered unsuitable for study participation.

Keywords: postoperative cognitive function delirium cardiac surgical procedures precision cardiac anesthesia
prospective validation study of high volume urine dna testing in individuals with suspicion of urothelial cancer

Conditions: Urothelial Carcinoma

Summary: urothelial cancers of the bladder and upper urinary tract account for over 200,000 deaths and 600,000 diagnoses annually worldwide. the most common presenting symptom is hematuria (blood in urine), triggering a cascade of tests, including an invasive examination of the bladder using a flexible scope (cystoscopy). millions of cystoscopies are performed every year worldwide for patients presenting with hematuria, but only 10% result in a cancer diagnosis. the uroscout-1 trial is a prospective multicenter observational study that explores the potential of urine tumor dna (utdna) testing to replace a significant portion of cystoscopies in the diagnostic setting for hematuria or other reasons to rule out urothelial cancer. the goal is to enhance patient quality of life, reduce healthcare costs, and address increased workloads in urology centers. sample collection will be conducted by mail, and the samples will be analyzed in a blinded manner, without knowledge of which patients are diagnosed with cancer. random subsampling will be applied to cancer-negative patients to achieve an approximate 1:1 ratio between cancer-positive and -negative patients.


Eligibility criteria:
inclusion criteria: * willing and able to provide informed consent * patient has been scheduled for cystoscopy to rule out urothelial cancer exclusion criteria: * prior diagnosis of urothelial cancer (i.e. bladder cancer or upper tract urothelial carcinoma)

Keywords: urothelial neoplasms bladder neoplasms upper tract urothelial neoplasms liquid biopsies urine tumor dna
ambulation study in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: this is a study comparing clinical tests of walking and balance. the goal of this study is to discover which of those tests are best at predicting walking problems due to ms.

this study includes: three study visits to the ms center at evergreen; wearing a pedometer for two, one-week periods to record walking during regular daily activities; keeping a diary for any walking problems such as falls and slips. subjects must meet the following criteria: diagnosis of ms (any form); 18-70 years of age; be on stable ms treatment or no ms treatment for the last three months; no scheduled hospitalization in the next six months.

Eligibility criteria:
inclusion criteria: * subject must have sufficient cognitive ability to maintain a falls diary and follow instructions for wearing the pedometer * subject must have clinically definite ms according to mcdonald criteria * subject must have edss between 0-6.5 * subject must be aged 18-70 * subjects must be given informed consent * subjects must be stable on disease modifying therapy or no therapy for at least three months before entry into study exclusion criteria: * no ms relapse within the last 30 days * subjects must have no scheduled major hospitalizations or surgical procedures during the study time frame. hospitalization during the study may result in removal from the study * medical conditions other than ms that might significantly impact ambulatory activity (such as angina pectoris) in the judgement of the investigators * history or suspicion of non-compliance in the judgement of the investigators

Keywords: mulitple sclerosis ambulation
cox-2 inhibitor with concurrent chemoradiation in locally advanced head & neck carcinoma

Conditions: Head and Neck Cancer

Summary: chemotherapy- and radiotherapy-induced oral mucositis represents a therapeutic challenge frequently encountered in cancer patients.this side effect causes significant morbidity and may delay or interrupt the treatment plan, as well reduce therapeutic index. cyclo-oxygenase 2 (cox-2) is an inducible enzyme primarily expressed in inflamed tissues and tumor. cox-2 inhibitors have shown promise as radio- and chemosensitizer and reduce radio-induced toxicities. we have conducted a phase iii, randomized double blind clinical trial to evaluate the toxicity and efficacy of celecoxib, a selective cox-2 inhibitor, administered concurrently with chemotherapy, and radiation for locally advanced head and neck cancer.


Eligibility criteria:
inclusion criteria: * stage iii/iv (locally advanced) carcinoma of oropharynx, oral cavity, hypopharynx, larynx, or nasopharynx * primary treatment with chemoradiation exclusion criteria: * distant metastasis * incomplete treatment * adjuvant chemoradiation after surgery without apparent tumor

Keywords: cox2 inhibitor head and neck cancer chemoradiation
validation of the prostate cancer assay - beta+pivotal

Conditions: Metastatic Prostate Cancer, CTC

Summary: the prostate cancer assay performance of celsee diagnostics circulating tumor cell (ctc) analysis system will be validated in patients diagnosed with metastatic prostate cancer. it will demonstrate substantial performance equivalency to a ctc assay predicate device.


Eligibility criteria:
inclusion criteria: * • male aged 18 years and above * be willing to sign an informed consent document indicating that the subject understands the purpose of and procedures required for the study and are willing to participate in the study * be willing/able to adhere to the prohibitions and restrictions specified in this protocol * eastern cooperative group (ecog) performance status ≤2 * documented histologically confirmed adenocarcinoma of the prostate * metastatic prostate cancer to the bone as documented by positive bone scan imaging * crpc patient being considered for systemic therapy or in between lines of therapies (\>= 14 days from prior treatment) for metastatic disease. patient must have evidence of castrate resistant prostate cancer as evidenced by a confirmed rising psa (per prostate cancer working group 2 \[pcwg2\] criteria) and a castrate serum testosterone level (i.e. ≤ 50 mg/dl). exclusion criteria: * • subjects actively receiving systemic therapy regimens, or between lines of therapies (\< 14 days from prior treatment) * have any condition that, in the opinion of the investigator, would compromise the wellbeing of the subject or the study or prevent the subject from meeting or performing study requirements * active infection or other medical condition that would make corticosteroids (i.e. prednisone) use contraindicated * uncontrolled hypertension (systolic bp ≥ 160 mmhg or diastolic bp ≥ 95 mmhg) patients with a history of hypertension are allowed provided blood pressure is controlled by antihypertensive treatment * severe hepatic impairment (child-pugh class c) * history of pituitary or adrenal dysfunction (note: the use of daily steroids does not exclude someone from participating in this study) * have poorly controlled diabetes (hgb a1c ≥ 8%) * any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule. * abnormal bone marrow function (absolute neutrophil count \[anc\] \< 1500/mm3, platelet count \<100,000/mm3, hemoglobin \<9 g/dl) * abnormal liver function (bilirubin \> upper limit of normal \[uln\]; ast and/or alt \> 1.5 x uln concomitant with alkaline phosphatase \> 2.5 x uln) * abnormal kidney function (serum creatinine ≥ 2 x upper limit of normal) * clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, unstable atrial fibrillation, or new york heart association (nyha) class iii-iv heart disease * history of ventricular tachyarrhythmia within the past 5 years
incidence and predictive factors of intestinal injury in patients undergoing heart valve replacements

Conditions: Injury of Other and Multiple Parts of Small Intestine

Summary: the purpose of this study is to investigate the incidence and predictive factors related to intestinal injury in patients undergoing heart valve replacement through a multicenter study in china.

intestinal injury is one of main reasons for mobidity and mortality after heart valve replacement, but its incidence and potential risk factors remain unclear. a multicenter study in china is undertaken to investigate the incidence and predictive factors related to intestinal injury in patients undergoing heart valve replacement.

Eligibility criteria:
inclusion criteria: * patients undergoing heart valve replacements under cardiopulmonary bypass exclusion criteria: * patients who die during or after operation
safety and tolerability of ranibizumab in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration

Conditions: Subfoveal Choroidal Neovascularization (CNV); Secondary to Age-related Macular Degeneration (AMD)

Summary: this extension study will investigate the long-term safety and tolerability of multiple intravitreal injections of ranibizumab administered to patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration who have been previously treated in either of the two ongoing ranibizumab studies crfb002a2302 (excite) or crfb002a2303 (sustain


Eligibility criteria:
inclusion criteria: * completion of 12-month treatment period of study crfb002a2302 (excite) or crfb002a2303 exclusion criteria: * concurrent participation in another clinical trial, i.e. use of other investigational drugs

Keywords: age-related macular degeneration (amd), choroidal neovascularization (cnv), vascular endothelial growth factor (vegf)
orelabrutinib with r-chop-like regimen for patients with newly diagnosed untreated non-gcb dlbcl

Conditions: Diffuse Large B-Cell Lymphoma

Summary: the purpose of this study is to evaluate the efficacy and safety of orelabrutinib combined with rituximab，followed by orelabrutinib combined with r-chop-like regimen for newly diagnosed untreated non-gcb dlbcl patients

the study will start with an initial 21-days of induction therapy with orelabrutinib and rituximab，following imaging examinations to evaluate response rates. then treatment with 6 cycles chemoimmunotherapy (r-chop-like) either alone or in combination with orelabrutinib will depend on response during induction phase. each cycle is 21 days.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed non-gcb dlbcl 2. age ≥18 and ≤70 years 3. at least one measurable lesion，measurable lymph nodes or masses of at least 15 millimeter (mm) 4. ecog performance status 0-2 5. lymphoma international prognostic score (ipi) ≥ 2 6. life expectancy ≥ 6 months 7. adequate organ and marrow function 8. agreement to practice birth control from the time of enrollment until the follow-up period of the study exclusion criteria: 1. received major surgery within 4 weeks before treatment or existed unhealed wounds or ulcers, except biopsy related to lymphoma diagnosis 2. all patients with primary central nervous system lymphoma 3. history of stroke or intracranial hemorrhage within 6 months before screening, require or receive anticoagulant therapy with warfarin or an equivalent antagonist 4. requires treatment with strong /moderate cyp3a inhibitors or inducers 5. uncontrolled comorbidity or complications, including but not limited to: symptomatic congestive heart failure (new york heart association class iii-iv) or symptomatic or poorly controlled arrhythmias and/or significant pulmonary disease 6. hiv infection and/or active hepatitis b or active hepatitis c infection 7. uncontrolled active systemic infection 8. known hypersensitivity or contraindications to any drug involved in the study 9. pregnant or lactating women

Keywords: orelabrutinib
on-q pump vs epidural for postoperative pain control in children

Conditions: Postoperative Pain

Summary: open abdominal and pelvic surgery or thoracotomy (open chest surgery) is frequently performed for tumor excision in children. post-operative pain management regimens are often at the discretions of the attending surgeon and may include opiods, patient administered analgesia (pca), epidural catheters, subcutaneous analgesia catheters or nsaids to control incisional pain. currently, both epidural or subcutaneous analgesia catheters (on-q pumps) are commonly used for children undergoing these operations, at the discretion of the surgeon. there are no studies comparing these regimens in children. the purpose of this study is to compare postoperative pain control of the two strategies.

the study design is a randomized, controlled trial to compare the effectiveness of on-q pump subcutaneous incisional analgesia to epidural analgesia for postoperative pain relief in children undergoing open abdominal, thoracic, or pelvic operations for oncologic purposes. the patient and treating team will be blinded to the pain control device. the primary outcome is additional narcotic usage for 3 post-operative days, and secondary outcomes are pain scores for 3 post-operative days, post-surgical day of ambulation, time to regular diet, infectious complications (uti, wound infection or pneumonia), and hospital length of stay. outcomes from both groups will be directly compared in order to determine whether one strategy provides more effective pain control with less complications than the other, or whether they are equivalent.

Eligibility criteria:
inclusion criteria: * weight \> 5kg * age younger than 19 years of age * planned abdominal, pelvic or thoracic operation for an oncologic indication exclusion criteria: * patients deemed inappropriate for placement of epidural by anesthesiologist * minimally invasive operation * biopsy through limited incision * history of chronic narcotic or opioid use * history of drug abuse

Keywords: postoperative pain, on-q pump, epidural, children
severe influenza trial of arbidol

Conditions: Influenza

Summary: this is a multicenter, randomised, double-blind, controlled study to assess the efficacy and safety of arbidol plus oseltamivir, compared with oseltamivir alone in approximately 200 hospitalized adults and adolescent patients with confirmed severe influenza. patients should be randomised as soon as possible after screening (no later than 12 hours), providing they are within 7 days of symptom onset. patients will be assigned in a 1:1 ratio to receive an arbidol plus oseltamivir, or oseltamivir plus placebo. rescreening of patients who fail to meet the inclusion and exclusion criteria will be permitted only once, providing the time from symptom onset to randomization is still within 7 days. arbidol/placebo will be administrated as 200mg tid from days 1-7. oseltamivir will be administered as 75mg twice daily from days 1-7 (dose to be adjusted for renal impairment). oseltamivir could be continued till influenza pcr negative. both drugs, along with the corresponding placebo for arbidol, will be started at the time of randomization.


Eligibility criteria:
inclusion criteria: 1. hospitalized males or females with a positive pcr test for influenza virus infection 2. age ≥16 years at the time of signing informed consent form 3. arterial oxygen saturation (sao2)/ pulse oxygen saturation (spo2) ≤94% in room air condition 4. ≤ 7 days since symptom onset. the onset of symptoms is defined as either: time of the first increase in body temperature (an increase of at least 1ºc from normal body temperature- ≥38℃); time when the patient experiences at least one general or respiratory symptom. 5. willingness to use contraception for 7 days after the end of treatment exclusion criteria: 1. physicians make a decision that trial involvement is not in patients' best interest, or any condition that does not allow the protocol to be followed safely. 2. patient refusal to accept invasive organ support treatment if needed 3. more than 3 consecutive doses of nais within 2 days before enrolment (including oseltamivir, zanamivir, peramivir) 4. women who are pregnant (including a positive pregnancy test at enrolment), breastfeeding, or within 2 weeks post-partum. the following female subjects do not need to undergo a pregnancy test at enrolment: a. postmenopausal (defined as cessation of regular menstrual periods for 2 years or more and confirmed by a follicle-stimulating hormone test) women. b. women who are surgically sterile by hysterectomy, bilateral oophorectomy, or tubal ligation. 5. any condition requiring renal replacement therapy 6. severe liver disease (child-pugh score ≥ c) 7. a history of hypersensitivity to arbidol or oseltamivir (tamiflu®) 8. currently or have been involved in another anti-influenza treatment trial in the last 28 days 9. patients who, in the opinion of the investigator, would be unlikely to comply with required study visits, self-assessments, and interventions

Keywords: severe influenza, arbidol, oseltamivir, ordinal scale